83134 Federal Register / Vol. 88, No. 227 / Tuesday, November 28, 2023 / Notices 

compliance determination if applicable. 

The certificate issuance fees will be set 

by CMS at levels sufficient to recover 

the full costs of administering the 

operational provisions of CLIA, 

including approval and monitoring of 

proficiency testing programs and 

accrediting bodies and implementing 

Federal requirements. Fees will also be 

collected by CMS to cover the costs of 

inspecting non-accredited laboratories 

and validating accrediting laboratories 

based on the lab’s volume and scope of 

testing. Currently, CMS contracts with 

50 State agencies to conduct surveys of 

all participating health care facilities. As 

part of their contract, CMS reimburses 

the State agencies for the reasonable 

cost of conducting surveys. This 

information collection gathers the 

information necessary to reimburse 

State agencies for a reasonable cost. 

Form Number: CMS–102 and CMS–105 

(OMB control number: 0938–0599); 

Frequency: Yearly/Quarterly; Affected 

Public: State, Local or Tribal 

Governments; Number of Respondents: 

50; Total Annual Responses: 50; Total 

Annual Hours: 34. (For policy questions 

regarding this collection contact Eric 

Powell at 312–886–0791). 

Dated: November 22, 2023. 

William N. Parham, III, 

Director, Paperwork Reduction Staff, Office 

of Strategic Operations and Regulatory 

Affairs. 

[FR Doc. 2023–26201 Filed 11–27–23; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2023–N–4597] 

Agency Information Collection 

Activities; Proposed Collection; 

Comment Request; Shortages Data 

Collections 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA, Agency, or we) is 

announcing an opportunity for public 

comment on the proposed collection of 

certain information by the Agency. 

Under the Paperwork Reduction Act of 

1995 (PRA), Federal agencies are 

required to publish notice in the 

Federal Register concerning each 

proposed collection of information, 

including each proposed extension of an 

existing collection of information, and 

to allow 60 days for public comment in 

response to the notice. This notice 

solicits comments on information 

collections associated with Shortages 

Data Collections and with notifications 

to FDA of an interruption or permanent 

discontinuance in manufacturing of 

certain medical devices as required by 

the Federal Food, Drug, and Cosmetic 

Act (FD&C Act). 

DATES: Either electronic or written 

comments on the collection of 

information must be submitted by 

January 29, 2024. 

ADDRESSES: You may submit comments 

as follows. Please note that late, 

untimely filed comments will not be 

considered. The https://

www.regulations.gov electronic filing 

system will accept comments until 

11:59 p.m. Eastern Time at the end of 

January 29, 2024. Comments received by 

mail/hand delivery/courier (for written/ 

paper submissions) will be considered 

timely if they are received on or before 

that date. 

Electronic Submissions 

Submit electronic comments in the 

following way: 

• Federal eRulemaking Portal: 

https://www.regulations.gov. Follow the 

instructions for submitting comments. 

Comments submitted electronically, 

including attachments, to https:// 

www.regulations.gov will be posted to 

the docket unchanged. Because your 

comment will be made public, you are 

solely responsible for ensuring that your 

comment does not include any 

confidential information that you or a 

third party may not wish to be posted, 

such as medical information, your or 

anyone else’s Social Security number, or 

confidential business information, such 

as a manufacturing process. Please note 

that if you include your name, contact 

information, or other information that 

identifies you in the body of your 

comments, that information will be 

posted on https://www.regulations.gov. 

• If you want to submit a comment 

with confidential information that you 

do not wish to be made available to the 

public, submit the comment as a 

written/paper submission and in the 

manner detailed (see ‘‘Written/Paper 

Submissions’’ and ‘‘Instructions’’). 

Written/Paper Submissions 

Submit written/paper submissions as 

follows: 

• Mail/Hand Delivery/Courier (for 

written/paper submissions): Dockets 

Management Staff (HFA–305), Food and 

Drug Administration, 5630 Fishers 

Lane, Rm. 1061, Rockville, MD 20852. 

• For written/paper comments 

submitted to the Dockets Management 

Staff, FDA will post your comment, as 

well as any attachments, except for 

information submitted, marked and 

identified, as confidential, if submitted 

as detailed in ‘‘Instructions.’’ 

Instructions: All submissions received 

must include the Docket No. FDA– 

2023–N–4597 for ‘‘Agency Information 

Collection Activities; Proposed 

Collection; Comment Request; Shortages 

Data Collections.’’ Received comments, 

those filed in a timely manner (see 

ADDRESSES), will be placed in the docket 

and, except for those submitted as 

‘‘Confidential Submissions,’’ publicly 

viewable at https://www.regulations.gov 

or at the Dockets Management Staff 

between 9 a.m. and 4 p.m., Monday 

through Friday, 240–402–7500. 

• Confidential Submissions—To 

submit a comment with confidential 

information that you do not wish to be 

made publicly available, submit your 

comments only as a written/paper 

submission. You should submit two 

copies total. One copy will include the 

information you claim to be confidential 

with a heading or cover note that states 

‘‘THIS DOCUMENT CONTAINS 

CONFIDENTIAL INFORMATION.’’ The 

Agency will review this copy, including 

the claimed confidential information, in 

its consideration of comments. The 

second copy, which will have the 

claimed confidential information 

redacted/blacked out, will be available 

for public viewing and posted on 

https://www.regulations.gov. Submit 

both copies to the Dockets Management 

Staff. If you do not wish your name and 

contact information to be made publicly 

available, you can provide this 

information on the cover sheet and not 

in the body of your comments and you 

must identify this information as 

‘‘confidential.’’ Any information marked 

as ‘‘confidential’’ will not be disclosed 

except in accordance with 21 CFR 10.20 

and other applicable disclosure law. For 

more information about FDA’s posting 

of comments to public dockets, see 80 

FR 56469, September 18, 2015, or access 

the information at: https://

www.govinfo.gov/content/pkg/FR-2015- 

09-18/pdf/2015-23389.pdf. 

Docket: For access to the docket to 

read background documents or the 

electronic and written/paper comments 

received, go to https://

www.regulations.gov and insert the 

docket number, found in brackets in the 

heading of this document, into the 

‘‘Search’’ box and follow the prompts 

and/or go to the Dockets Management 

Staff, 5630 Fishers Lane, Rm. 1061, 

Rockville, MD 20852, 240–402–7500. 

FOR FURTHER INFORMATION CONTACT: 

Amber Sanford, Office of Operations, 

Food and Drug Administration, Three 


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Federal Register / Vol. 88, No. 227 / Tuesday, November 28, 2023 / Notices 83135 

1Under section 506J of the FD&C Act, 

manufacturers of the following devices must notify 

FDA of an interruption or permanent 

discontinuance in manufacturing: 

• Devices that are critical to public health during 

a public health emergency, including those that are 

life-supporting, life-sustaining, or intended for use 

in emergency medical care or during surgery; or 

• Devices for which FDA determines information 

on potential meaningful supply disruptions is 

needed during a public health emergency. See 

section 506J(a)(1), (2) of the FD&C Act. 

2See section 506J(a) of the FD&C Act. 

3https://www.fda.gov/media/155245/download. 

4https://www.fda.gov/media/173800/download. 

White Flint North, 10A–12M, 11601 

Landsdown St., North Bethesda, MD 

20852, 301–796–8867, PRAStaff@

fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: Under the 

PRA (44 U.S.C. 3501–3521), Federal 

agencies must obtain approval from the 

Office of Management and Budget 

(OMB) for each collection of 

information they conduct or sponsor. 

‘‘Collection of information’’ is defined 

in 44 U.S.C. 3502(3) and 5 CFR 

1320.3(c) and includes Agency requests 

or requirements that members of the 

public submit reports, keep records, or 

provide information to a third party. 

Section 3506(c)(2)(A) of the PRA (44 

U.S.C. 3506(c)(2)(A)) requires Federal 

agencies to provide a 60-day notice in 

the Federal Register concerning each 

proposed collection of information, 

including each proposed extension of an 

existing collection of information, 

before submitting the collection to OMB 

for approval. To comply with this 

requirement, FDA is publishing notice 

of the proposed collection of 

information set forth in this document. 

With respect to the following 

collection of information, FDA invites 

comments on these topics: (1) whether 

the proposed collection of information 

is necessary for the proper performance 

of FDA’s functions, including whether 

the information will have practical 

utility; (2) the accuracy of FDA’s 

estimate of the burden of the proposed 

collection of information, including the 

validity of the methodology and 

assumptions used; (3) ways to enhance 

the quality, utility, and clarity of the 

information to be collected; and (4) 

ways to minimize the burden of the 

collection of information on 

respondents, including through the use 

of automated collection techniques, 

when appropriate, and other forms of 

information technology. 

Shortages Data Collections 

OMB Control Number 0910–0491— 

Extension 

Under section 1003(d)(2) of the FD&C 

Act (21 U.S.C. 393(d)(2)), the 

Commissioner of Food and Drugs is 

authorized to implement general powers 

(including conducting research) to carry 

out effectively the mission of FDA. After 

the events of September 11, 2001, and 

as part of broader counterterrorism and 

emergency preparedness activities, 

FDA’s Center for Devices and 

Radiological Health (CDRH) began 

developing operational plans and 

interventions that would enable CDRH 

to anticipate and respond to medical 

device shortages that might arise in the 

context of federally declared disasters/ 

emergencies or regulatory actions. In 

particular, CDRH identified the need to 

acquire and maintain detailed data on 

domestic inventory, manufacturing 

capabilities, distribution plans, and raw 

material constraints for medical devices 

that would be in high demand and/or 

would be vulnerable to shortages in 

specific disaster/emergency situations 

or following specific regulatory actions. 

Such data could support prospective 

risk assessment, help inform risk 

mitigation strategies, support real-time 

decision making by the Department of 

Health and Human Services (HHS) 

during actual emergencies or emergency 

preparedness exercises, and mitigate or 

prevent harm to the public health. 

This voluntary data collection process 

consists of outreach to firms that have 

been identified as producing or 

distributing medical devices that may be 

considered essential to the response 

effort. In this initial outreach, the intent 

and goals of the data collection effort 

will be described, and the specific data 

request made. Data are collected, using 

the least burdensome methods, in a 

structured manner to answer specific 

questions. After the initial outreach, we 

will request updates to the information 

periodically to keep the data current 

and accurate. Additional followup 

correspondence may occasionally be 

needed to verify/validate data, confirm 

receipt of followup correspondence(s), 

and/or request additional details to 

further inform FDA’s public health 

response. 

The Coronavirus Aid, Relief, and 

Economic Security Act (CARES Act) 

(Pub. L. 116–136) was enacted on March 

27, 2020. Section 3121 of the CARES 

Act amended the FD&C Act by adding 

section 506J to the FD&C Act (21 U.S.C. 

356j). Section 506J of the FD&C Act 

provides FDA with new authorities 

intended to help prevent or mitigate 

medical device shortages by requiring 

medical device manufacturers to inform 

FDA about changes in device 

manufacturing that could potentially 

lead to a device shortage. Apprised with 

that information, section 506J of the 

FD&C Act authorizes FDA to take 

several actions that may help to mitigate 

or avoid supply disruptions. 

Section 506J of the FD&C Act requires 

manufacturers of certain devices,1 to 

notify FDA ‘‘of a permanent 

discontinuance in the manufacture of 

the device’’ or ‘‘an interruption of the 

manufacture of the device that is likely 

to lead to a meaningful disruption in 

supply of that device in the United 

States’’ during or in advance of a 

declared public health emergency, and 

the reason for such discontinuance or 

interruption.2 Section 506J of the FD&C 

Act requires FDA to take action based 

on that information, including (1) 

publicly posting a list of devices it 

determines to be in shortage, (2) 

publicly posting the reasons for the 

shortage, and (3) issuing letters to 

manufacturers that fail to comply with 

the notification requirements of section 

506J of the FD&C Act. 

On December 29, 2022, the Prepare 

for and Respond to Existing Viruses, 

Emerging New Threats, and Pandemics 

Act was signed into law as part of the 

Consolidated Appropriations Act, 2023 

(Pub. L. 117–328) (hereafter referred to 

as the ‘‘FY 2023 Omnibus’’). Section 

2514(c) of the fiscal year (FY) 2023 

Omnibus directed FDA to issue or revise 

guidance regarding requirements under 

section 506J of the FD&C Act and 

include a list of each device product 

code for which a manufacturer of such 

device is required to notify FDA in 

accordance with section 506J. Section 

2514 of the FY 2023 Omnibus amended 

section 506J of the FD&C Act to add 

section 506J(h), ‘‘Additional 

Notifications’’ and directed FDA to 

issue guidance ‘‘to facilitate voluntary 

notifications.’’ 

In the Federal Register of November 

17, 2023 (88 FR 80310), FDA announced 

the availability of the final guidance 

entitled ‘‘Notifying FDA of a Permanent 

Discontinuance or Interruption in 

Manufacturing of a Device Under 

Section 506J of the FD&C Act’’ 3 and the 

draft guidance entitled ‘‘Select Updates 

for the 506J Guidance: 506J Device List 

and Additional Notifications.’’ 4 The 

final guidance, ‘‘Notifying FDA of a 

Permanent Discontinuance or 

Interruption in Manufacturing of a 

Device Under Section 506J of the FD&C 

Act’’ (hereafter referred to as the ‘‘506J 

Guidance’’) assists stakeholders in the 

Agency’s implementation of section 

506J. This guidance serves as the 

baseline for information about 

notifications under section 506J during 

or in advance of any public health 

emergency (PHE). FDA provides 

additional clarification on who is 


lotter on DSK11XQN23PROD with NOTICES1
83136 Federal Register / Vol. 88, No. 227 / Tuesday, November 28, 2023 / Notices 

required to notify FDA, when such 

notifications are required, what 

information FDA expects manufacturers 

to include in such notifications, and 

how to submit notifications. 

Additionally, FDA describes how FDA 

determines that a device is in shortage 

and additional actions FDA may take to 

help prevent or mitigate a potential 

device shortage. 

In the draft guidance ‘‘Select Updates 

for the 506J Guidance: 506J Device List 

and Additional Notifications,’’ FDA 

proposes updates to the 506J Guidance. 

Specifically, FDA has developed a list of 

devices, by FDA product code, for 

which a manufacturer of such devices is 

required to notify FDA in accordance 

with section 506J (hereafter referred to 

as the ‘‘506J Device List’’). The 506J 

Device List is based on the requirements 

under section 506J(a) of the FD&C Act. 

In section 2514 of the FY 2023 

Omnibus, Congress directed FDA to 

issue guidance on the requirements 

under section 506J and to include ‘‘a list 

of each device product code for which 

a manufacturer of such device is 

required to notify the Secretary in 

accordance with section 506J.’’ Thus, 

manufacturers of a device on the 506J 

Device List must notify FDA in 

accordance with 506J for each such 

device. For more information, 

manufacturers should see the 506J 

Device List web page, available at 

https://www.fda.gov/medical-devices/ 

medical-device-supply-chain-andshortages/506j-device-list. Additionally, 

consistent with section 506J(h), FDA is 

proposing to clarify for stakeholders that 

manufacturers may submit, and FDA 

may receive, voluntary notifications 

regarding supply chain issues at any 

time, unrelated to the declaration or 

potential declaration of a PHE. 

The guidance documents include 

additional voluntary items that 

manufacturers could provide the 

Agency, including additional 

information about device manufacturing 

and supply, and updates to initial 

notifications. 

Respondents may notify FDA about 

an interruption or permanent 

discontinuance in device manufacturing 

(506J notification) on our website at 

https://fda-cdrh.my.salesforcesites.com/shortages/. 

FDA estimates the burden of this 

collection of information as follows: 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1

Activity Number of 

respondents 

Number of 

responses per 

respondent 

Total 

annual 

responses 

Average burden per 

response 

(hours) 

Total hours 

Shortages outreach data collection ............................................................. 1,000 4 4,000 1 .................................. 4,000 

Information collection under section 506J ................................................... 8,400 1 8,400 0.25 (15 minutes) ....... 2,100 

Additional voluntary collections related to section 506J .............................. 8,400 1 8,400 0.25 (15 minutes) ....... 2,100 

Total ...................................................................................................... ........................ ........................ 20,800 ..................................... 8,200 

1There are no capital costs or operating and maintenance costs associated with this collection of information. 

I. Shortages Outreach Data Collection 

FDA bases these estimates on our 

recent experience and informal direct 

contact with respondents. We estimate 

up to 1,000 manufacturers, distributors, 

healthcare systems, healthcare 

providers, group purchasing 

organizations, and sterilizers for which 

there may be targeted outreach because 

their devices may be essential to the 

response effort. This targeted outreach 

will be conducted periodically either to 

obtain primary data or to verify/validate 

updated data (although additional 

outreach may be undertaken as needed). 

The data being requested represent 

common data elements that respondents 

monitor and track as part of routine 

business operations and, therefore, are 

readily available. It is anticipated that 

for most respondents, the estimated 

time to fulfill CDRH’s data request will 

not exceed 1 hour per request, or 4 

hours per year. 

II. Information Collection Under 

Section 506J of the FD&C Act and 

Related Voluntary Collections 

Based on current registration and 

listing data (approved under OMB 

control number 0910–0625), we 

estimate the number of respondents that 

will submit a notification under section 

506J of the FD&C Act to be 

approximately 20 percent of currently 

registered manufacturers. Data from our 

Registration and Listing system indicate 

that there are approximately 42,000 

unique FDA Establishment 

Identification registered manufacturers. 

Therefore, we estimate 8,400 

respondents per year. We believe that 

the burden, including the provision of 

required information under section 506J 

of the FD&C Act, as well as additional 

voluntary information (including 

additional issues that may impact the 

availability of the device, such as 

information about critical suppliers, 

potential mitigations, production 

capacity and market share, and 

notification updates), is minimal and 

such information is readily available to 

respondents. Therefore, we estimate the 

burden of this information collection to 

be 15 minutes or less per notification. 

Since the last OMB approval, we have 

updated the Number of Respondents 

and Average Burden per Response for 

the Shortages Outreach Data Collection 

element based on our recent experience 

with the information collection and 

informal direct contact with 

respondents. The updates result in an 

adjustment of an additional 3,000 hours 

and 2,000 responses annually. 

Dated: November 22, 2023. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2023–26199 Filed 11–27–23; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2022–E–2101] 

Determination of Regulatory Review 

Period for Purposes of Patent 

Extension; Korsuva 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA or the Agency) has 

determined the regulatory review period 

for Korsuva and is publishing this 

notice of that determination as required 

by law. FDA has made the 

determination because of the 

submission of an application to the 

Director of the U.S. Patent and 

Trademark Office (USPTO), Department 

of Commerce, for the extension of a 

patent which claims that human drug 

product. 


lotter on DSK11XQN23PROD with NOTICES1